# OZT: Balloon Aortic Valvuloplasty

- Device class: 2; regulation: 21 CFR 870.1255; FDA's rule: 510(k) required
- FDA decisions: 22
- 510(k) review time 2021–2025: median 191 days (middle half 113–272)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 3
- 2014: 4
- 2015: 4
- 2016: 1
- 2017: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K122012: Z-Med Z-Med II (2012), cited by 4
- DEN080015: Nucleus-X PTV Catheter (2012), cited by 4
- K133569: True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM (2013), cited by 3
- K121083: True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True Dilatation Percutaneous Translumina (2012), cited by 3
- K123111: V8 Transluminal Bav Catheter (2013), cited by 2
- K172932: True Flow Valvuloplasty Perfusion Catheter (2017), cited by 1
- K132728: V8 Transluminal Bav Catheter (2013), cited by 1
- K141985: True BA V Balloon Valvuloplasty Catheter (2014), cited by 1
- K140241: Edwards Transfemoral Balloon Catheter (2014), cited by 1
- K240967: ValvuloPro Valvuloplasty Balloon Catheter (2024), cited by 1

Source page: https://510kreport.com/product-code/OZT
Data by year (CSV): https://510kreport.com/product-code/OZT.csv